Injection of Lymphocytes From Haplo-identical Donor Following Chemotherapy in Patients With High-risk Acute Myeloblastic Leukemia Not Eligible for an Allogeneic Hematopoietic Stem Cell Transplantation (ILDA)

Nantes University Hospital (NUH)

Status and phase

Enrolling

Phase 1

Conditions

Acute Myeloid Leukemia (AML)

Treatments

Biological: DLI

Study type

Interventional

Funder types

Other

Identifiers

NCT04886206

RC20_0357

Details and patient eligibility

About

Patients with high risk AML non eligible for an intensive treatment and for an allogeneic transplantation will be treated with azacitidine and venetoclax. The fourth, fifth and sixth injection of azacitidine will be followed by injection of haplo-identical lymphocytes (HLI). This is a single-center phase I study to identify the dose of HLI with the most tolerable toxicity. TheBayesian continuous reassessment method (CRM) will be used

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age ≥18 years
patients with de novo or secondary AML, with an unfavorable or intermediate karyotype (according to the 2017 ELN classification), or patients with relapsing AML who may receive second-line treatment
not candidates for intensive induction, for the following reasons
- 75 years or ≥ 18 to 74 years and at least one of the following comorbidities: PS ≥ 2 or a history of heart failure requiring treatment or LVEF ≤ 50% or chronic stable angina or FEV1 ≤ 65% or DLCO ≤ 65% or creatinine clearance <45 ml / min; or liver damage with total bilirubin> 1.5 N or other comorbidities that the hematologist considers incompatible with intensive treatment
ineligible for a classic allogeneic hematopoietic stem cell transplant due to the presence of co-morbidities or too high a risk of toxicity >70 years old or at least one of the following comorbidities: PS ≥ 2 or a history of heart failure requiring treatment or LVEF ≤ 50% or chronic stable angina or FEV1 ≤ 65% or DLCO ≤ 65% or creatinine clearance <45 ml / min; or liver damage with total bilirubin> 1.5 N
may receive chemotherapy with hypomethylating agents have a partially compatible (haplo-identical) major family donor (≥18 years old) eligible for lymphocyte donation.

Exclusion criteria

AML with favorable karyotype (according to ELN 2017) in RC1
Patient with refractory or progressive AML
Other progressive cancer in progress
Karnosky index <60% or PS> 2
Severe hepatic function disturbance: transaminases> 5 N, hyperbilirubinemia> 30 µm / L
Severe infection requiring hospitalization.
Psychiatric illness compromising the understanding of the information or the carrying out of the study.
woman of childbearing potential and refusing an effective method of contraception.
Minor
Adult under tutorship or curatorship, under legal protection or under family authorization
Minor family donor (<18 years old)